Dual-deflecting electrophysiology catheter

ABSTRACT

An electrophysiology catheter includes a tubular body having a proximal region, a neck region, and a distal region predisposed into a loop and including electrodes. A first deflection wire extends through at least a portion of the proximal region of the catheter body and includes a first flattened section, while a second deflection wire extends through the neck region and at least a portion of the distal region and includes a second flattened section within the neck region. A first activation wire is joined to the flattened section of the first deflection wire, while a second activation wire is joined to the flattened section of the second deflection wire. Thus, forces acting on the first and second activation wires, such as forces imposed by a handle-based actuator, are respectively transmitted to the first and second deflection wires, thereby deflecting the proximal and neck regions, respectively.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/760,337, filed 14 Apr. 2010 (the '337 application), now U.S. Pat. No.8,369,923 (issued 5 Feb. 2013), which is hereby incorporated byreference as though fully set forth herein.

BACKGROUND OF THE INVENTION

a. Field of the Invention

The instant invention relates to catheters for use in medicalprocedures. In particular, the instant invention relates to anelectrophysiology catheter for use in diagnostic and therapeuticprocedures at or near an annular region of a patient's anatomy, such asthe ostium of a pulmonary vein.

b. Background Art

Catheters are used for an ever-growing number of procedures. Forexample, catheters are used for diagnostic, therapeutic, and ablativeprocedures, to name just a few examples. Typically, the catheter ismanipulated through the patient's vasculature and to the intended site,for example a site within the patient's heart.

A typical electrophysiology catheter includes an elongate shaft and oneor more electrodes on the distal end of the shaft. The electrodes may beused for ablation, diagnosis, or the like. Oftentimes, these electrodesare ring electrodes that extend about the entire circumference of thecatheter shaft.

One specific use of an electrophysiology catheter is to map the atrialregions of the heart, and in particular the pulmonary veins, which areoften origination points or foci of atrial fibrillation. Suchelectrophysiology mapping catheters typically have at least a partialloop shape at their distal end in order to surround the pulmonary veinostia. Because of varying patient anatomies, however, it may bechallenging to properly place the looped section of the catheterprecisely in the pulmonary vein ostia.

BRIEF SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide anelectrophysiology catheter having an enhanced ability to customize theshape of the catheter for a particular patient's individual anatomy.

Another object of the present invention is to provide anelectrophysiology catheter that allows the looped portion to deflectrelative to the remainder of the catheter body, thereby permitting theangle of the loop to be “fine tuned.”

According to a first aspect, the present invention provides anelectrophysiology catheter including: a tubular catheter body having aproximal region, a neck region, and a distal region predisposed into atleast a partial loop; a plurality of electrodes disposed on the distalregion; a handle joined to the proximal region; a first deflection wireextending through at least a portion of the proximal region of thecatheter body and including a first flattened section; a seconddeflection wire extending through the neck region and at least a portionof the distal region and including a second flattened section within theneck region; a first activation wire extending from the handle andjoined to the first flattened section of the first deflection wire suchthat forces acting on the first activation wire are transmitted to thefirst deflection wire in order to deflect the proximal region of thetubular catheter body; and a second activation wire extending from thehandle and joined to the second flattened section of the seconddeflection wire such that forces acting on the second activation wireare transmitted to the second deflection wire in order to deflect theneck region of the tubular catheter body. Optionally, the seconddeflection wire may be a shape memory material, such as nickel titanium.The second deflection wire may also be configured to include acylindrical section extending distally from the second flattened sectionthrough at least a portion of the distal region. In other embodiments ofthe invention, a spring coil is provided that surrounds at least aportion of the second activation wire.

Typically, the handle of the electrophysiology catheter will alsoinclude a first actuator operably coupled to the first activation wireand a second actuator operably coupled to the second activation wire. Insome embodiments of the invention, it is contemplated that theelectrophysiology catheter will include a third activation wire adaptedto alter a radius of curvature of the at least a partial loop. Likewise,the handle of the electrophysiology catheter may include a thirdactuator operably coupled to the third activation wire.

Also disclosed herein is an electrophysiology catheter including: anelongate catheter body including a proximal region, a distal region, anda neck region joining the distal region to the proximal region; aplurality of electrodes disposed on the distal region; a firstdeflection mechanism including a first flat wire disposed within theproximal region of the catheter body and operable to deflect theproximal region of the catheter body; a shape memory structure extendingthrough at least a portion of the distal region and shaping the portionof the distal region into at least a partial loop; and a seconddeflection mechanism including a second flat wire disposed within theneck region of the catheter body and operable to deflect the neck regionof the catheter body, wherein a distal end of the second flat wire iscoupled to a proximal end of the shape memory structure. Optionally, theshape memory structure may be operable to alter a radius of curvature ofthe at least a partial curve of the distal region.

It is contemplated that the first deflection mechanism and the seconddeflection mechanism respectively may deflect the proximal region andthe neck region of the catheter body in the same plane. Alternatively,the first deflection mechanism and the second deflection mechanismrespectively may deflect the proximal region and the neck region of thecatheter body in different planes. In general, the first deflectionmechanism includes a first activation wire coupled to the first flatwire such that forces acting on the first activation wire aretransferred to the first flat wire, while the second deflectionmechanism includes a second activation wire coupled to the second flatwire such that forces acting on the second activation wire aretransferred to the second flat wire. In turn, a handle coupled to theproximal region of the catheter body includes a first actuationmechanism operably coupled to the first activation wire and a secondactuation mechanism operably coupled to the second activation wire.

In yet another aspect, the present invention provides a method ofperforming an electrophysiology procedure. The method generally includesthe steps of: providing an electrophysiology catheter including aproximal region, a neck region, a distal region disposed into at least apartial loop, a plurality of electrodes disposed on the distal region, afirst deflection mechanism including a first flat wire operable todeflect the proximal region of the electrophysiology catheter, and asecond deflection mechanism including a second flat wire operable todeflect the neck region of the electrophysiology catheter; introducingthe electrophysiology catheter into a patient's body proximate an ostiumof interest; actuating the first deflection mechanism to deflect theproximal region of the catheter in order to orient the distal regiongenerally towards the ostium of interest; and actuating the seconddeflection mechanism to deflect the neck region of the catheter in orderto refine a position of the distal region relative to the ostium ofinterest. The electrophysiology catheter may also include a radius ofcurvature actuation mechanism that is operable to alter a radius ofcurvature of the at least a partial loop, such that the method may alsoinclude a step of actuating the radius of curvature actuation mechanismto adjust the radius of curvature of the at least a partial loop toconform to a shape of the ostium of interest.

An advantage of an electrophysiology catheter according to the presentinvention is that the distal region thereof, including the loop used inelectrophysiological procedures at or near an annular region, can bedeflected relative to the remainder of the catheter body.

Another advantage of an electrophysiology catheter according to thepresent invention is that its shape can be tailored to a particularpatient's individual anatomy.

The foregoing and other aspects, features, details, utilities, andadvantages of the present invention will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an exemplary electrophysiology catheter.

FIG. 2A is a close up of a portion of an electrophysiology catheteraccording to some embodiments of the present invention.

FIG. 2B is an end view of the electrophysiology catheter of FIG. 2A.

FIG. 3A is a close up of a portion of an electrophysiology catheteraccording to additional embodiments of the present invention.

FIG. 3B is an end view of the electrophysiology catheter of FIG. 3A.

FIG. 4 is a cross-sectional view of the electrophysiology catheter ofFIG. 1 taken along line A-A.

FIG. 5 depicts the deflection of the proximal region of theelectrophysiology catheter of FIG. 1.

FIG. 6 depicts the deflection of both the proximal region and the neckregion of the electrophysiology catheter of FIG. 1.

FIG. 7 is a cross-sectional view of the electrophysiology catheter ofFIG. 1 taken along line B-B.

FIG. 8 depicts the deflection of the neck region of theelectrophysiology catheter of FIG. 1.

FIG. 9 depicts one configuration for varying the radius of curvature ofthe loop of the distal region of the catheter of FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will be described with reference to anelectrophysiology catheter utilized in cardiac electrophysiologystudies, such as the Livewire Spiral HP™ and Inquiry™ Optima™ PLUScatheters of St. Jude Medical, Inc. It should be understood, however,that the present teachings may be applied to good advantage in othercontexts as well.

Referring now to the figures, FIG. 1 depicts an electrophysiology (“EP”)catheter 10 according to a first aspect of the present invention.

EP catheter 10 generally includes an elongate catheter body 12, which,in some embodiments, is tubular (e.g., it defines at least one lumentherethrough). Catheter body 12 includes a proximal region 14, a distalregion 16, and a neck region 18 between proximal region 14 and distalregion 16. One of ordinary skill in the art will appreciate that therelative lengths of proximal region 14, distal region 16, and neckregion 18 depicted in FIG. 1 are merely illustrative and may varywithout departing from the spirit and scope of the present invention. Ofcourse, the overall length of catheter body 12 should be long enough toreach the intended destination within the patient's body.

Catheter body 12 will typically be made of a biocompatible polymericmaterial, such as polytetrafluoroethylene (PTFE) tubing (e.g., TEFLON®brand tubing). Of course, other polymeric materials, such as fluorinatedethylene-propylene copolymer (FEP), perfluoroalkoxyethylene (PFA),poly(vinylidene fluoride), poly(ethylene-co-tetrafluoroethylene), andother fluoropolymers, may be utilized. Additional suitable materials forcatheter body 12 include, without limitation, polyamide-basedthermoplastic elastomers (namely poly(ether-block-amide), such asPEBAX®), polyester-based thermoplastic elastomers (e.g., HYTREL®),thermoplastic polyurethanes (e.g., PELLETHANE®, ESTANE®), ionicthermoplastic elastomers, functionalized thermoplastic olefins, and anycombinations thereof. In general, suitable materials for catheter body12 may also be selected from various thermoplastics, including, withoutlimitation, polyamides, polyurethanes, polyesters, functionalizedpolyolefins, polycarbonate, polysulfones, polyimides, polyketones,liquid crystal polymers and any combination thereof. It is alsocontemplated that the durometer of catheter body 12 may vary along itslength. In general, the basic construction of catheter body 12 will befamiliar to those of ordinary skill in the art, and thus will not bediscussed in further detail herein.

As seen in FIGS. 2A, 2B, 3A, and 3B, distal region 16 of catheter body12 is predisposed into at least a partial loop. As one of ordinary skillin the art will appreciate, this loop shape allows distal region 16 toconform to the shape, for example, of a pulmonary vein ostium. One ofordinary skill in the art will also appreciate that the partial loop maytake a number of configurations, depending on the intended or desireduse of EP catheter 10, consistent with the present teachings. Therefore,it should be understood that the circular and elliptical loopconfigurations depicted in FIGS. 2B and 3B, respectively, are merelyillustrative.

FIGS. 2A, 2B, 3A, and 3B also illustrate that distal region 16 includesa plurality of electrodes 20 disposed thereon. One of ordinary skill inthe art will appreciate that electrodes 20 may be ring electrodes or anyother electrodes suitable for a particular application of EP catheter10. For example, where EP catheter 10 is intended for use in acontactless electrophysiology study, electrodes 20 may be configured asdescribed in U.S. application Ser. No. 12/496,855, filed 2 Jul. 2009,which is hereby incorporated by reference as though fully set forthherein. Of course, in addition to serving sensing purposes (e.g.,cardiac mapping and/or diagnosis), electrodes 20 may be employed fortherapeutic purposes (e.g., cardiac ablation and/or pacing).

Referring again to FIG. 1, a handle 22 is coupled to proximal region 14of catheter body 12. Handle 22 includes suitable actuators (e.g., knob24) to control the deflection of catheter body 12 described in furtherdetail below. Various handles and their associated actuators for use inconnection with electrophysiology catheters are known, and thus handle22 will not be described in further detail herein.

FIG. 4 is a cross-section of catheter body 12 taken along line A-A inFIG. 1 (e.g., within proximal region 14). An interior lumen 26 ofcatheter body 12 is visible. Also visible is a first deflection wire 28,a first activation wire 30, a second activation wire 32 (discussed infurther detail below), and a collection of conductor wires 34 forconducting power and/or signals to and/or from electrodes 20.

First deflection wire 28 extends through at least a portion of proximalregion 14 of catheter body 12. Preferably, first deflection wire 28includes a first flattened section, as this configuration promotesdeflection along a first axis while inhibiting deflection along otheraxes. One suitable material for first deflection wire 28 is stainlesssteel, though other materials can be employed without departing from thespirit and scope of the present invention.

First activation wire 30 extends from handle 22, where it is coupled toa suitable actuator, and is joined to the first flattened section offirst deflection wire 28, for example by soldering. As such, forcesacting on first activation wire 30, for example tension resulting frompractitioner acting on a suitable actuator provided on handle 22, aretransmitted to first deflection wire 28, thereby deflecting proximalregion 14 of catheter body 12. Deflection of proximal region 14 is shownin FIGS. 5 and 6. For example, FIG. 6 shows proximal region 14deflecting from a generally straight configuration (shown in phantom) inthe direction of arrow 36 to a curve of approximately 180 degrees (shownin solid lines).

FIG. 7 is a cross-section of catheter body 12 taken along line B-B inFIG. 1 (e.g., within neck region 18). Visible in FIG. 7 are a seconddeflection wire 38, second activation wire 32, and conductors 34.

Second deflection wire 38 extends through neck region 18, and, in someembodiments of the invention, through at least a portion of distalregion 16. Second deflection wire 38 also includes a second flattenedsection within neck region 18. Preferably, second deflection wire 38 ismade of a shape memory material such as nickel titanium (e.g., Nitinol).

Second activation wire 32 extends from handle 22, where it is coupled toa suitable actuator, and is joined to the second flattened section ofsecond deflection wire 38, for example by soldering. As such, forcesacting on second activation wire 32, for example tension resulting frompractitioner acting on a suitable actuator provided on handle 22, aretransmitted to second deflection wire 38, thereby deflecting neck region18 of catheter body 12. Deflection of neck region 18 is shown in FIGS. 6and 8. For example, FIG. 8 shows, in phantom, neck region 18 deflectedsuch that distal region 16 is no longer perpendicular to the remainderof catheter body 12 (e.g., deflection in the direction of arrow 40 shownin FIG. 6). This additional deflection advantageously allows apractitioner to “fine tune” the orientation of the loop of distal region16. That is, by not limiting the plane of the loop of distal region 16to being orthogonal to the longitudinal axis of catheter body 12, apractitioner can tailor the shape of EP catheter 10 to a particularpatient's individual anatomy, thereby facilitating electrophysiologyprocedures.

At least a portion of second activation wire 32 may be surrounded by aspring coil 42. Spring coil 42 stabilizes neck region 18 when seconddeflection wire 38 is activated by second activation wire 32. The innerdiameter of spring coil 42 is preferably slightly larger than thediameter of second activation wire 32.

As described above, in some embodiments of the invention, seconddeflection wire 32 extends distally into distal region 16. In theseembodiments of the invention, the shape memory material of seconddeflection wire 32 may also serve to predispose distal region 16 intothe looped configuration. That is, it is contemplated that seconddeflection wire 32 may also serve as a shaping wire for distal region16. Optionally, the portion of second deflection wire 32 that extendsinto distal region 16 may be of a different cross-sectionalconfiguration than the portion of second deflection wire extendingthrough neck region 18. For example, the more distal portion of seconddeflection wire 32 may have a cylindrical cross-section, as opposed tothe flat cross-section of the more proximal portion thereof.

It is also contemplated that the radius of curvature of the loop ofdistal region 16 may be adjustable, for example to conform to thevarying sizes of pulmonary vein ostia of patients of different ages.This additional control may be provided, for example, by providing athird activation wire, such as wire 44, adapted to alter the radius ofcurvature of the loop of distal region 16. In some embodiments of theinvention, one end (e.g., the distal end) of third activation wire 44may be coupled to the tip of catheter body 12 (e.g., coupled to a tipelectrode 46), while the other end (e.g., the proximal end) of thirdactivation wire 44 may be coupled to a suitable actuator on handle 22.For example, FIG. 9 illustrates a configuration where pulling onactivation wire 44 will cause distal region 16 to bend into or out ofthe plane of the page, thereby altering the radius of curvature of theloop of distal region 16.

Alternatively, in embodiments of the invention where second deflectionwire 32 extends distally into distal region 16, second deflection wire32 may itself serve as the activation wire that alters the radius ofcurvature of the loop. Still another mechanism for varying the radius ofcurvature of the loop of distal region 16 is described in U.S.application Ser. No. 12/004,643, filed 21 Dec. 2007, and herebyincorporated by reference as though fully set forth herein.

In use, EP catheter 10 is introduced into a patient's body proximate anarea of interest, such as a pulmonary vein ostium. Of course, EPcatheter may be introduced surgically (e.g., via an incision in thepatient's chest) or non-surgically (e.g., navigated through thepatient's vasculature to a desired site). First deflection wire 28 maybe actuated in order to deflect proximal region 14 of catheter body 12such that distal region 16 is oriented generally towards the ostium ofinterest. Thereafter, second deflection wire 38 may be actuated todeflect neck region 18 of catheter body 12 in order to “fine tune” theposition of distal region 16 relative to the ostium of interest. Wheresuch additional refinement is desirable, the radius of curvature of theloop of distal region 16 may also be adjusted. Electrodes 20 may then beemployed for diagnostic or therapeutic purposes.

Although several embodiments of this invention have been described abovewith a certain degree of particularity, those skilled in the art couldmake numerous alterations to the disclosed embodiments without departingfrom the spirit or scope of this invention. For example, though FIG. 6depicts proximal region 14 and neck region 18 of catheter body 12deflecting in the same plane, the deflection mechanisms (e.g., firstdeflection wire 28/first activation wire 30 and second deflection wire38/second activation wire 32) may instead be oriented such that proximalregion 14 and neck region 18 of catheter body 12 depict in differentplanes. As another example, though FIG. 6 depicts only unidirectionaldeflection, either or both of proximal region 14 and neck region 18 maybe configured for bidirectional deflection in a single plane and/orunidirectional or bidirectional deflection in multiple planes.

All directional references (e.g., upper, lower, upward, downward, left,right, leftward, rightward, top, bottom, above, below, vertical,horizontal, clockwise, and counterclockwise) are only used foridentification purposes to aid the reader's understanding of the presentinvention, and do not create limitations, particularly as to theposition, orientation, or use of the invention. Joinder references(e.g., attached, coupled, connected, and the like) are to be construedbroadly and may include intermediate members between a connection ofelements and relative movement between elements. As such, joinderreferences do not necessarily infer that two elements are directlyconnected and in fixed relation to each other.

It is intended that all matter contained in the above description orshown in the accompanying drawings shall be interpreted as illustrativeonly and not limiting. Changes in detail or structure may be madewithout departing from the spirit of the invention as defined in theappended claims.

What is claimed is:
 1. An electrophysiology catheter comprising: atubular catheter body having a proximal region, a neck region, and adistal region predisposed into at least a partial loop disposed in aplane; at least one electrode disposed on the distal region; a handlejoined to the proximal region; a first deflection mechanism extendingfrom the handle through at least a portion of the proximal region of thecatheter body to facilitate deflection of the proximal region of thetubular catheter body such that the at least a partial loop of thedistal region deflects from the plane; and a second deflection mechanismextending from the handle through the neck region and at least a portionof the distal region to deflect the neck region of the tubular catheterbody such that the at least a partial loop of the distal region deflectsfrom the plane.
 2. The electrophysiology catheter of claim 1, wherein atleast a portion of the first deflection mechanism comprises a firstflattened section extending through at least a portion of the proximalregion of the catheter body.
 3. The electrophysiology catheter of claim2, wherein the first deflection mechanism comprises a first activationwire extending from the handle and joined to the first flattenedsection.
 4. The electrophysiology catheter of claim 1, wherein at leasta portion of the second deflection mechanism comprises a secondflattened section extending through the neck region and at least aportion of the distal region.
 5. The electrophysiology catheter of claim4, wherein the second deflection mechanism comprises a second activationwire extending from the handle and joined to the second flattenedsection.
 6. The electrophysiology catheter of claim 1, furthercomprising means for altering a radius of curvature of the at least apartial loop.
 7. An electrophysiology catheter comprising: a tubularcatheter body having a proximal region, a neck region, and a distalregion predisposed into at least a partial loop disposed in a plane; atleast one electrode disposed on the distal region; a first deflectionassembly operable to deflect the proximal region of the tubular catheterbody such that the at least a partial loop of the distal region deflectsfrom the plane; a second deflection assembly operable to deflect theneck region of the tubular catheter body such that the at least apartial loop of the distal region deflects from the plane; and a handlejoined to the proximal region, the handle comprising: a first actuatoroperably coupled to the first deflection assembly; and a second actuatoroperably coupled to the second deflection assembly.
 8. Theelectrophysiology catheter of claim 7, wherein the first deflectionassembly comprises a first deflection wire, and wherein the firstdeflection wire comprises a first flattened section extending through atleast a portion of the proximal region of the catheter body.
 9. Theelectrophysiology catheter of claim 8, wherein the first deflectionassembly further comprises a first activation wire extending from thehandle and joined to the first flattened section of the first deflectionwire.
 10. The electrophysiology catheter of claim 7, wherein the seconddeflection assembly comprises a second deflection wire, and wherein thesecond deflection wire comprises a second flattened section extendingthrough the neck region and at least a portion of the distal region. 11.The electrophysiology catheter of claim 10, wherein the seconddeflection assembly further comprises a second activation wire extendingfrom the handle and joined to the second flattened section of the seconddeflection wire.
 12. The electrophysiology catheter of claim 7, furthercomprising means for altering a radius of curvature of the at least apartial loop.
 13. The electrophysiology catheter of claim 7, wherein theat least a partial loop of the distal region comprises an active region.14. The electrophysiology catheter of claim 13, wherein the activeregion comprises a plurality of electrodes.
 15. An electrophysiologycatheter comprising: a tubular catheter body having a proximal region, aneck region, and a distal region predisposed into at least a partialloop disposed in a plane; at least one electrically-active regiondisposed on the distal region; a handle joined to the proximal region,the handle comprising a first actuator and a second actuator; a firstdeflection mechanism comprising a first deflection wire operably coupledto the first actuator such that actuation of the first actuator causesdeflection in the proximal region that causes the at least a partialloop of the distal region to deflect from the plane; and a seconddeflection mechanism comprising a second deflection wire operablycoupled to the second actuator such that actuation of the secondactuator causes deflection in the neck region that causes the at least apartial loop of the distal region to deflect from the plane.
 16. Theelectrophysiology catheter of claim 15, wherein at least a portion ofthe first deflection mechanism comprises a first flattened sectionextending through at least a portion of the proximal region of thecatheter body.
 17. The electrophysiology catheter of claim 16, whereinthe first deflection mechanism comprises a first activation wireextending from the handle and joined to the first flattened section. 18.The electrophysiology catheter of claim 15, wherein at least a portionof the second deflection mechanism comprises a second flattened sectionextending through the neck region and at least a portion of the distalregion.
 19. The electrophysiology catheter of claim 18, wherein thesecond deflection mechanism comprises a second activation wire extendingfrom the handle and joined to the second flattened section.
 20. Theelectrophysiology catheter of claim 15, further comprising means foraltering a radius of curvature of the at least a partial loop.